Light Adjustable Lens (LAL) 60007-0220Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00818806021620), received between Jun 27, 2024 and Jun 11, 2026 — classified as 27 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+) WAS EXPLANTED FROM THE LEFT EYE DUE TO MONOCULAR DIPLOPIA AND BLURRY VISION. A NEW LAL WAS IMPLANTED AS A REPLACEMENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Blurred Vision; Diplopia/Double Vision

  MAUDE report 25473395 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+) WAS EXPLANTED DUE TO A CHANGE IN VISUAL ACUITY AND THE PATIENT'S COMPLAINT OF "HAZE" AFTER COMPLETION OF LOCK-IN TREATMENTS AND A NEW LAL+ IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 25449323 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN: (B)(6), +22.0D) WAS EXPLANTED DUE TO "HIGHER ORDER ABERRATIONS IN THE LENS" AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN: (B)(6), +22.5D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 24385450 ↗
• InjuryFeb 12, 2026Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS+ (LAL+, (B)(6), +22.0D) WAS IMPLANTED IN THE RIGHT EYE ON (B)(6) 2023. THE PATIENT HAD 2 LIGHT ADJUSTMENTS AND NO LOCK-IN TREATMENTS POST-OPERATIVELY. UPON RETURNING TO CLINIC ON (B)(6) 2025, THE PATIENT COMPLAINED OF BLURRY VISION. THE PATIENT HAD AN ADDITIONAL LIGHT TREATMENT ON (B)(6) 2025 AND RETURNED TO CLINIC ON (B)(6) 2025 COMPLAINING OF CONTINUED BLURRY VISION AND HALOS. SLIT LAMP EXAM FOUND A CENTRAL AREA OF DISTORTION THAT IS CONSISTENT WITH PHOTOPOLYMERIZATION. THE LAL+ WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2025 AND REPLACED WITH ANOTHER LAL (SN (B)(6), +22.0D).

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24328594 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.0D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Disturbances

  MAUDE report 24317270 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +22.0D) WAS EXPLANTED DUE TO THE PATIENT'S DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 24317269 ↗
• InjuryJan 7, 2026Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH THE LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.0D) IN THE LEFT EYE ON (B)(6) 2025. POSTOPERATIVELY, THE PATIENT UNDERWENT 3 LIGHT ADJUSTMENT AND NO LOCK-IN TREATMENTS. THE PATIENT SELF-REPORTED THAT THEY DID NOT WEAR THE RXSIGHT UV SPECTACLES DURING THE POST-OPERATIVE PERIOD "AT TIMES" OUTSIDE. THE LAL+ WAS EXPLANTED ON (B)(6) 2025. DURING THE EXPLANT PROCEDURE, THE SURGEON NOTED A LENS APPEARANCE CONSISTENT WITH POLYMERIZATION.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 23998930 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT WAS IMPLANTED WITH A LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.0D) ON (B)(6) 2024. THE PATIENT COMPLETED 3 LIGHT ADJUSTMENTS AND NO LOCK-IN TREATMENTS. AFTER 3 TREATMENTS, THE TREATING PHYSICIAN NOTED THAT THE PATIENT WAS EXPERIENCING ANISOMETROPIA AND A LENS EXCHANGE WAS RECOMMENDED ON (B)(6) 2024. APPROXIMATELY 17 MONTHS AFTER IMPLANTATION, ON (B)(6) 2025, THE PATIENT PRESENTED TO THE CLINIC COMPLAINING OF BLURRY VISION AND VISUAL DISTURBANCES; THE LENS WAS EXPLANTED ON (B)(6) 2025.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 23658805 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.0D) WAS EXPLANTED FROM THEIR RIGHT EYE DUE TO BLURRY VISION AND DIPLOPIA. A NEW LAL+ (SN (B)(6), +21.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision; Diplopia/Double Vision

  MAUDE report 23487817 ↗
• InjurySep 17, 2025Use of Device Problem; Use of Device Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.0D) WAS IMPLANTED IN THE RIGHT EYE (B)(6) 2025. POSTOPERATIVELY, THE PATIENT UNDERWENT 1 LIGHT ADJUSTMENT AND NO LOCK-IN TREATMENTS. ON (B)(6) 2025, THE LAL+ WAS EXPLANTED AND REPLACED WITH A NEW LAL+. THE SITE REPORTED THAT THE EXPLANTED LENS HAS A "WARPED" APPEARANCE CONSISTENT WITH POLYMERIZATION. THE PATIENT REPORTED TO THE TREATING PHYSICIAN THAT THEY DID NOT WEAR THE PROVIDED UV PROTECTIVE EYEWEAR WHILE "GARDENING."

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 23073857 ↗
• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A BILATERALLY IMPLANTED PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.0D) WAS EXPLANTED FROM THE RIGHT EYE DUE TO PATIENT DISSATISFACTION WITH THE CHOSEN REFRACTIVE TARGET.

  Patient problems: Blurred Vision

  MAUDE report 22953574 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.0D) WAS EXPLANTED DUE TO BLURRY VISION AND VISUAL DISTURBANCES.

  Patient problems: Blurred Vision

  MAUDE report 22669485 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, (B)(6), +22.0D) WAS EXPLANTED DUE TO MONOCULAR DIPLOPIA AND A LIGHT ADJUSTABLE LENS (+22.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Diplopia/Double Vision

  MAUDE report 22567017 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A CAPSULE TEAR OCCURRED DURING IMPLANTATION OF THE LIGHT ADJUSTABLE LENS+ (LAL+, SN: (B)(6), +22.0D). THE LAL WAS PLACED IN THE SULCUS AND A VITRECTOMY WAS PERFORMED.

  Patient problems: Capsular Bag Tear

  MAUDE report 22567015 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6) , +22.0D) WAS EXPLANTED DUE TO THE PATIENT'S DISSATISFACTION WITH VISION AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6) , +22.0D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22538607 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.0D) WAS IMPLANTED ON (B)(6) 2024. THE HAPTIC OF THE LAL+ WAS OBSERVED TO BE ANTERIOR TO THE IRIS DURING THE POSTOPERATIVE DAY 1 VISIT AND WAS REPOSITIONED. THE PATIENT HAD PERSISTENT VISUAL DISTURBANCES AND MONOCULAR DIPLOPIA DURING THE POSTOPERATIVE PERIOD FIRST NOTICED ON (B)(6) 2024. ON (B)(6) 2025, THE LAL+ WAS EXPLANTED DUE TO VISUAL DISTURBANCES.

  Patient problems: Diplopia/Double Vision; Visual Disturbances

  MAUDE report 22510450 ↗
• InjuryJul 3, 2025Scratched Material; Scratched Material

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.0D) WAS EXPLANTED DUE TO LENS ABNORMALITIES NOTED PRIOR TO LIGHT TREATMENTS. A NEW LAL+ (SN (B)(6), +21.5D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 22399743 ↗
• InjuryJun 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A SITE REPORTED TO RXSIGHT THAT A SECONDARY SURGERY WAS SUCCESSFULLY PERFORMED ON A PATIENT WITH THE LIGHT ADJUSTABLE LENS+ (LAL+, (B)(6), +22.0D) FOLLOWING FINAL LOCK IN TO REMOVE DEBRIS FROM THE LENS THAT WAS CAUSING VISUAL DISTURBANCES. SYMPTOMS WERE RESOLVED AND THE LENS WAS NOT EXPLANTED.

  Patient problems: Visual Disturbances

  MAUDE report 22293007 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.0) WAS EXPLANTED DUE TO BLURRY VISION.

  Patient problems: Blurred Vision

  MAUDE report 22287278 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.0D) WAS EXPLANTED DUE TO PATIENT DISSATISFACTION WITH THEIR VISION. A NEW LAL WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 22040825 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.0D) WAS EXPLANTED FROM A PATIENT WITH A HISTORY OF OCULAR SURFACE DISEASE AND FOVEAL HYPOPLASIA DUE TO UNHAPPINESS WITH VISION QUALITY. A LAL (SN (B)(6), +21.0D) WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 21688203 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.0D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES AND BLURRY VISION AND A NEW LIGHT ADJUSTABLE LENS (LAL, SN (B)(6), +20.5D) IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21574553 ↗
• InjuryFeb 25, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  A SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.0D) WAS EXPLANTED DUE TO AN INCORRECTLY CHOSEN IOL POWER. A NEW LAL+ (SN (B)(6), +10.0D) WITH A DIFFERENT IOL POWER WAS IMPLANTED AS A REPLACEMENT.

  Patient problems: Visual Impairment

  MAUDE report 21462857 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SITE REPORTED TO RXSIGHT THAT A LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.0D) WAS EXPLANTED DUE TO VISUAL DISTURBANCES.

  Patient problems: Visual Disturbances

  MAUDE report 21149629 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SITE REPORTED TO RXSIGHT THAT A PATIENT'S LIGHT ADJUSTABLE LENS+ (LAL+, SN (B)(6), +22.0D) WAS EXPLANTED DUE TO BLURRY CENTRAL VISION AND MONOCULAR DIPLOPIA AND A NEW LAL (SN (B)(6), +23.0D) IMPLANTED AS A REPLACEMENT. RXSIGHT'S FIRST AWARENESS OF THIS EVENT WAS ON 08/23/2024.

  Patient problems: Visual Disturbances

  MAUDE report 20251530 ↗